2019 Ryan White HIV/AIDS Program CLINICAL CONFERENCE

Ipergay Results

HIV Incidence (mITT Analysis)

Follow-Up Pts-years

HIV Incidence per 100 Pts-years (95% CI)

Treatment

Placebo (double-blind)

212

6.60 (3.60-11.1)

TDF/FTC (double-blind)

219

0.91 (0.11-3.30)

TDF/FTC (open-label)

515

0.19 (0.01-1.08)

MedianFollow-up in Open-LabelPhase18.4 months (IQR:17.5-19.1)

97% relative reduction vs. placebo

Median # pills/month: 18 (IQR 11-25)

Molina et al, Lancet HIV 2017;4:e402-10

Slide19of58FromHScott,MD,MPHatNewOrleans,LA,December4-7, 2019,RyanWhiteHIV/AIDS ProgramCLINICAL CONFERENCE, IAS  USA.

What about less frequent sex?

• An analysis of IPERGAY study evaluating 269 patients (134 person- yrs) who took on-demand TDF/FTC PrEP less frequently (<15 pills/month ) AND reported using PrEP systematically or often during sexual intercourse

IPERGAY RCT 2017 Sub-analysis

Median # sex acts/month

10

5

Median # pills taken/month

15

9.5

HIV incidence rate/100 py (95% CI)

Person years

# HIV infections

P

Placebo

64.8

6

9.3 (3.4- 20.1)

TDF/FTC

68.9

0

0.0 (0.0-5.4)

0.013

Antonietal,AIDS 2017

Slide20of58FromHScott,MD,MPHatNewOrleans,LA,December4-7, 2019,RyanWhiteHIV/AIDS ProgramCLINICAL CONFERENCE, IAS  USA.

Recommendations for 2-1-1 TDF/FTC PrEP

• CDC continues to recommend daily TDF/FTC PrEP only ▫ only licensed indication by FDA

• IAS-USA guidelines recommend 2-1-1 TDF/FTC PrEP as alternative to daily PrEP for MSM ▫ Use if can plan ahead for pre-dose, can take post-doses, use with all partners ▫ Does not avoid adverse events

• Daily TDF/FTC PrEP is the only recommended option for cis- and transgender women and PWID

Slide22of58FromHScott,MD,MPHatNewOrleans,LA,December4-7, 2019,RyanWhiteHIV/AIDS ProgramCLINICAL CONFERENCE, IAS  USA.